Commentary on the US Food and Drug Administration’s 2011 “Guidance for Industry, Process Validation General Principles and Practices”

Impact ................................................................................................. 18 2.2.7 General Commentary on PVG Scope and Purpose ............................ 19

2.3 Part 3: 2011 Final Version of the PVG ............................................................20 2.3.1 Legacy Processes ................................................................................26 2.3.2 Re: ASTM E2500-07 .......................................................................... 35

2.4 Part 4: Final Thoughts .................................................................................... 47 References ................................................................................................................48

For years, the industry had been asking for more ¨exibility in designing the experiments and tests needed to validate processes. Some have expressed the opinion that at times regulatory requirements are not aligned with scientiŒc principles. The thought is that the industry has the higher level of understanding of their manufacturing processes and therefore more expertise at qualifying and validating those processes. Performing equipment qualiŒcation and process validation without sound scientiŒc principles and risk-based objectives have resulted in ineffective process control and inefŒcient validation programs.